Metoprolol Tartrate

Product NDC
10544-879
11-digit product format
105440879
Labeler code
10544
Product ID
10544-879_1eb06538-0a13-0db4-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA074217
Marketing category
ANDA
Marketing start
1994-05-27
Marketing end
0000-00-00
Substance
METOPROLOL TARTRATE
Active strength
50 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10544-879IInactivated by FDA2026-08-17
excluded packagepackage10544-87910544-879-14IInactivated by FDA2026-08-17
excluded packagepackage10544-87910544-879-20IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 66 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10544-879-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10544-879-14d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10544-879-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10544-879-14f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10544-879-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10544-879-142ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10544-879-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10544-879-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10544-879-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10544-879-14cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10544-879-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10544-879-14cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10544-879-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10544-879-14302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10544-879-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10544-879-14ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10544-879-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10544-879-140efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10544-879-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10544-879-14ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10544-879-20367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10544-879-14367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10544-879-20557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10544-879-14557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10544-879-208af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10544-879-148af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10544-879-20834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10544-879-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10544-879-201332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10544-879-141332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage10544-879-20fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage10544-879-14fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage10544-879-2086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage10544-879-1486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage10544-879-20bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage10544-879-14bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage10544-879-208dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage10544-879-148dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage10544-879-20e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage10544-879-14e2bbac7714bc…27bdfed8d636…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074217-001METOPROLOL TARTRATEMETOPROLOL TARTRATE50MGTABLET / ORAL1994-05-27
A074217-002METOPROLOL TARTRATEMETOPROLOL TARTRATE100MGTABLET / ORAL1994-05-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-27caaa826d4ba7…
2026-08-18 06:07:402026-07A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074217-001METOPROLOL TARTRATE50MGTABLET / ORAL1994-05-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074217-002METOPROLOL TARTRATE100MGTABLET / ORAL1994-05-27bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A074217-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A074217-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074217-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A074217-002AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac0d979-ed64-4395-be9a-fc0b6f8c0a4fProduct name120260122
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
07ea0487-5434-6896-2497-013a7ee4afbdProduct name920250311
95ced987-af5e-4bea-8119-4e7d4558d21bProduct name220200617
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
9ab5a42a-e77d-486b-bb1f-b343fe664adaProduct name120180430
310125de-e7c0-730d-d178-98b990a0334aProduct name220150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-879-142020-01-31C16284748780-19d75b9d1-28cb-f424-e053-dadaa90a57ceMetoprolol Tartrate Tabs
10544-879-202020-01-31C16284748780-19d75b9d1-28cb-f424-e053-dadaa90a57ceMetoprolol Tartrate Tabs

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-879-14Metoprolol Tartrate14 in 1 BOTTLE, PLASTICTABLET, FILM COATED141
10544-879-20Metoprolol Tartrate20 in 1 BOTTLE, PLASTICTABLET, FILM COATED201

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933METOPROLOL TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETOPROLOL TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BMETOPROLOL TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOPROLOL TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETOPROLOL TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMETOPROLOL TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EMETOPROLOL TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METOPROLOL TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMETOPROLOL TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-879METOPROLOL TARTRATE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 2 package rows20150901_1eb06538-0a12-0db4-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866514metoprolol tartrate 50 MG Oral TabletPSN1eb06538-0a12-0db4-e054-00144ff88e881
866514metoprolol tartrate 50 MG Oral TabletSCD1eb06538-0a12-0db4-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-879-141054408791414 in 1 BOTTLE, PLASTICHistorical
10544-879-201054408792020 in 1 BOTTLE, PLASTICHistorical